ThunderCell Battery Lamination Kit

GUDID 08057971590728

ThunderCell Battery Lamination Kit

BIONIT LABS SRL

Myoelectric hand prosthesis

• Primary Device ID: 08057971590728
• NIH Device Record Key: 954bcc16-ff23-4ddd-b767-5b9399a3c89d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThunderCell Battery Lamination Kit
• Version Model Number: MKEB01
• Company DUNS: 439080477
• Company Name: BIONIT LABS SRL
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com
• Phone: +3908361946903
• Email: support@bionitlabs.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057971590728 [Primary]

FDA Product Code

• IQZ: Hand, External Limb Component, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-19
• Device Publish Date: 2024-08-09

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